The institutions of the European Union have published the updated texts of the new Directive and Regulation which together constitute the reform of the EU pharmaceutical regulatory framework.

The reform represents the most significant overhaul of the European Union’s pharmaceutical regulatory framework in over two decades and introduces substantial changes across a broad range of areas governing medicinal products, from development and marketing authorisation through to market access and security of supply.

The reform addresses, inter alia, the following areas:

• Regulatory data and market protection — the reform reshapes the rules governing the protection of data submitted in support of a marketing authorisation and the subsequent period of regulatory market protection. These forms of regulatory protection are distinct from patent protection and play a key role in product protection and lifecycle management strategies, including by affecting the timing of market entry of generic and biosimilar medicinal products.
• Marketing authorisation procedures and the role of the EMA — the new framework seeks to streamline and increase the efficiency of assessment and authorisation procedures, including by shortening the applicable scientific assessment timelines, while strengthening patient representation within the Committee for Medicinal Products for Human Use (CHMP).
• Orphan medicinal products — the incentive framework applicable to medicinal products for rare conditions is revised, including the criteria for orphan designation, the applicable incentives, the regime governing breakthrough orphan medicinal products and the rules concerning the duration and extension of market exclusivity.
• Paediatric medicinal products — the provisions governing the development and authorisation of medicinal products for the paediatric population are incorporated into the new legislative framework.
• Generic and biosimilar medicinal products — the scope of the so-called Bolar exemption is clarified and further harmonised at EU level, specifying the activities preparatory to market entry that may be carried out without infringing applicable patent rights or supplementary protection certificates.
• Antimicrobials — new incentive mechanisms are introduced to support the research and development of antimicrobials, including specific incentives for priority antimicrobials, as part of the broader EU response to antimicrobial resistance.
• Availability of medicinal products and management of shortages — the new framework strengthens obligations relating to the monitoring, prevention and management of shortages and provides for EU-level mechanisms concerning medicinal products identified as critical.
• Environmental considerations — greater emphasis is placed on the environmental risk assessment of medicinal products and on the adoption of appropriate measures to prevent or mitigate the identified environmental risks.

The Directive and the Regulation must now be formally adopted and subsequently published in the Official Journal of the European Union.

Both acts will enter into force on the twentieth day following their publication. As a general rule, the Regulation will apply 24 months after its entry into force, while Member States will be required to transpose and apply the Directive within the same 24-month period, subject in each case to the specific transitional arrangements and application dates laid down in the respective acts.